Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes from Baseline in BNP and CVP after the infusion of rhBNP
研究概览
简要总结
The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.
详细描述
CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained from patient's legally acceptable representative.
- •Pediatric patients after Repair of Tetralogy Of Fallot.
排除标准
- •Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
- •Treatment or planned treatment with another investigational drug within 3 months of screening.
- •Known hypersensitivity to bosentan or any of the excipients
- •cardiogenic shock and inclination of hypotension（SBP< 60mmHg）.
研究组 & 干预措施
rhBNP Group
Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a rhBNP infusion 24 hours after operation. The dose of recombinant human brain natriuretic peptide (rhBNP) will be 1.5 mcg/kg for loading, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.
干预措施: recombinant human brain natriuretic peptide (rhBNP) (Drug)
Placebo Group
Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.
干预措施: Placebo (0.9% sodium chloride) (Drug)
结局指标
主要结局
Changes from Baseline in BNP and CVP after the infusion of rhBNP
时间窗: 12 months after operation of Tetralogy Of Fallot
we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure.
次要结局
- Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen(12 months after operation of Tetralogy Of Fallot)
研究者
Xu Zhuoming
Vice Chief, Department of thoracic and cardiovascular surgery
Shanghai Jiao Tong University School of Medicine